When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. Surrounded by collaborative colleagues, you’ll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an exceptional strategy for the near term and beyond. Take your place on our strong team, and help us make significant contributions to the world.
- Lead and manage quality team to support new product development, address product quality and process issues in meeting continual quality improvement and compliance objectives.
- Manage and develop quality team, as assigned.
- Drive new product development quality and ensure consistent and compliance product development process. Support DHF development and ensure documentation is robust and processes are validated before transfer to manufacturing. Ensure compliance to regulatory requirement.
- Lead VOC efforts to improve product and service quality. Chair CQT meeting and schedule PQT meeting to drive product quality issues and to provide timely communication to stakeholders.
- Build quality into products through active participation in Development, Manufacturing and Supply chain activities
- Communicate with supplier quality to ensure suppliers meet our specifications and quality objectives for materials.
- Drive and monitor quality programs/ issues that include: Failure Investigation, Complaint,
- Drive CAPA, Risk Management, Validation and other improvements activities through PPI initiatives.
- Support Quality systems to ensure compliance to regulatory, accreditation and system requirements. Balance compliance needs with effective and efficient implementation on product and process changes.
- Support plant wide activities and special projects, as assigned
- Degree in Engineering (Mechanical or Electronics) or Degree in Sciences
- 5 years of working in a Quality Assurance function with managerial experience
- Relevant working experience in ISO13485 and GMP environment preferred
- Ability to contribute in a global matrix organisation effectively.
- Demonstrate leadership and implement change management.
- Able to think strategically and creatively.
- High standard of quality requirement.
- Ability to lead, mentor and facilitate problem solving and quality improvement process.
- Quality systems knowledge ISO9001, ISO13485, ISO14971 and 21CFR Part 820 requirements
At Thermo Fisher Scientific, each one of our 50,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status